| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
| 510(k) Number |
K896633 |
| Device Name |
AUTO-CUFF(TM) |
| Applicant |
| U.S. Medical Corp. |
| 408 Highland Avenlue |
| P.O. Box 580 |
|
Cheshire,
CT
06410
|
|
| Applicant Contact |
BRUCE E DODSON |
| Correspondent |
| U.S. Medical Corp. |
| 408 Highland Avenlue |
| P.O. Box 580 |
|
Cheshire,
CT
06410
|
|
| Correspondent Contact |
BRUCE E DODSON |
| Regulation Number | 870.1130 |
| Classification Product Code |
|
| Date Received | 11/22/1989 |
| Decision Date | 02/01/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|